Z-1901-2011

Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients...

Name: Z-1901-2011 Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients...
Creator: Gambro Renal Products, Incorporated
Published: 2011-03-14
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2011-03-14 / Terminated / root cause: software

FDA source

Gambro Renal Products, Incorporated began a recall of Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload on 2011-03-14. The reason FDA records is "Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1901-2011
Status: Terminated
Initiated: 2011-03-14
Posted: 2011-04-06
Terminated: 2011-09-01
Recalling firm: Gambro Renal Products
Product: Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.
Root cause tag: software
FDA root cause: Software change control
Action: The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: [email protected]. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).
Quantity in commerce: 1300 units
Distribution: Nationwide distribution.
Product codes and lots: All units with Version 3.20 software.

Product code KDI

K072093Class IIPrismaflex System, Version 3.20Gambro / cleared 2008-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)